The following data is part of a premarket notification filed by Medicon Instruments, Inc. with the FDA for Medicon Instruments Cholangiography Needles, Guide Tubes, Injection Needles, Verres Insufflation Needles And Holders.
| Device ID | K936248 |
| 510k Number | K936248 |
| Device Name: | MEDICON INSTRUMENTS CHOLANGIOGRAPHY NEEDLES, GUIDE TUBES, INJECTION NEEDLES, VERRES INSUFFLATION NEEDLES AND HOLDERS |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | MEDICON INSTRUMENTS, INC. COLUBMIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Howard M Mholstein |
| Correspondent | Howard M Mholstein MEDICON INSTRUMENTS, INC. COLUBMIA SQUARE 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-30 |
| Decision Date | 1994-05-16 |